Tirzepatide for Adolescent Obesity
Recruiting in Palo Alto (17 mi)
+84 other locations
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Eli Lilly and Company
Disqualifiers: Type 1 diabetes, Type 2 diabetes, Pancreatitis, Medullary thyroid carcinoma, others
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 6 Jurisdictions
Trial Summary
What is the purpose of this trial?
The goal of the study is to assess how tirzepatide impacts bodyweight and cardiovascular risk factors when used in conjunction with healthy nutrition and physical activity in adolescents with obesity and multiple weight related comorbidities. The study will last approximately 76 weeks and may include up to 23 visits.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug Tirzepatide for adolescent obesity?
Is tirzepatide safe for humans?
What makes the drug Tirzepatide unique for treating adolescent obesity?
Research Team
C1
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Principal Investigator
Eli Lilly and Company
Eligibility Criteria
This trial is for adolescents with obesity and weight-related health issues. Participants should be committed to a healthy diet and exercise routine. Details on specific inclusion or exclusion criteria are not provided, but typically these would involve age range, BMI thresholds, and absence of conditions that could interfere with the study.Inclusion Criteria
Have history of at least 1 self-reported unsuccessful dietary effort to lose weight
My BMI is in the top 5% for my age and sex, and I have at least two conditions like high blood pressure, prediabetes, or high triglycerides.
I can sign the consent form myself or have someone legally authorized to do so.
Exclusion Criteria
I plan to or have had surgery to help me lose weight.
I or my family have a history of medullary thyroid cancer or MEN2.
I have lost more than 5 kg in weight in the last 3 months without trying.
See 3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive tirzepatide or placebo subcutaneously once weekly
72 weeks
Up to 23 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- Tirzepatide (Other)
Trial OverviewThe study tests Tirzepatide's effectiveness in reducing body weight and improving heart health risks compared to a placebo. It spans roughly 76 weeks with up to 23 check-ins, where participants will also follow prescribed nutrition and physical activity plans.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TirzepatideExperimental Treatment1 Intervention
Participants will receive tirzepatide subcutaneously (SC).
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive placebo SC.
Tirzepatide is already approved in United States, European Union, Canada, Australia, United States, United Kingdom for the following indications:
🇺🇸 Approved in United States as Mounjaro for:
- Type 2 diabetes
🇪🇺 Approved in European Union as Mounjaro for:
- Type 2 diabetes
🇨🇦 Approved in Canada as Mounjaro for:
- Type 2 diabetes
🇦🇺 Approved in Australia as Mounjaro for:
- Type 2 diabetes
🇺🇸 Approved in United States as Zepbound for:
- Weight loss
- Moderate to severe obstructive sleep apnea
🇬🇧 Approved in United Kingdom as Zepbound for:
- Weight loss
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Consano Clinical Research, LLCShavano Park, TX
Alberta Children's HospitalCalgary, Canada
Kids ClinicAjax, Canada
Dr. Steven V. Zizzo Medicine Professional CorporationHamilton, Canada
More Trial Locations
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Who Is Running the Clinical Trial?
Eli Lilly and Company
Lead Sponsor
Trials
2708
Patients Recruited
3,720,000+
Findings from Research
Tirzepatide, a once-weekly medication for type 2 diabetes, not only improves blood sugar control but also leads to significant weight loss and positive changes in cardiovascular health, such as reduced blood pressure and improved insulin sensitivity.
The weight loss and metabolic benefits of tirzepatide are linked to its dual action as a GIP and GLP-1 receptor agonist, suggesting that these mechanisms play a crucial role in its effectiveness for managing type 2 diabetes.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Perspectives on weight control in diabetes - Tirzepatide.Várkonyi, TT., Pósa, A., Pávó, N., et al.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Tirzepatide: Clinical review of the "twincretin" injectable.Krauss, Z., Hintz, A., Fisk, R.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Adverse Events Related to Tirzepatide.Mishra, R., Raj, R., Elshimy, G., et al.[2023]
Tirzepatide, a dual GLP-1/GIP receptor co-agonist, has been shown to significantly reduce glycosylated hemoglobin levels (1.87% to 3.02%) and body weight (5.4 to 12.9 kg) in people with type 2 diabetes over treatment periods of up to 104 weeks, demonstrating its efficacy compared to placebo and other diabetes medications.
In individuals without diabetes, tirzepatide also led to substantial weight loss (16.5% to 22.4%) over 72 weeks, indicating its potential for obesity management as well.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Efficacy and Safety of Tirzepatide in Type 2 Diabetes and Obesity Management.Sinha, R., Papamargaritis, D., Sargeant, JA., et al.[2023]
Tirzepatide is a novel medication that acts on both GIP and GLP-1 receptors, enhancing insulin secretion and reducing glucagon levels, which helps improve glycemic control in adults with type 2 diabetes mellitus (T2DM).
It received its first approval in the USA in May 2022 for T2DM treatment and is currently being studied for additional conditions like obesity, heart failure, and non-alcoholic steatohepatitis, indicating its potential for broader therapeutic applications.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Tirzepatide: First Approval.Syed, YY.[2022]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Tirzepatide, a dual GIP/GLP-1 receptor co-agonist for the treatment of type 2 diabetes with unmatched effectiveness regrading glycaemic control and body weight reduction.Nauck, MA., D'Alessio, DA.[2022]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Efficacy and Safety of Tirzepatide in Adults With Type 2 Diabetes: A Perspective for Primary Care Providers.Kushner, P., Anderson, JE., Simon, J., et al.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Tirzepatide, the Newest Medication for Type 2 Diabetes: A Review of the Literature and Implications for Clinical Practice.Bradley, CL., McMillin, SM., Hwang, AY., et al.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Beyond the Guidelines: A Narrative Review of Treatments on the Horizon for Migraine in Children and Adolescents.VanderPluym, JH., Victorio, MCC., Oakley, CB., et al.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
The pharmacotherapeutic management of episodic and chronic migraine with gepants.Tajti, J., Szok, D., Csáti, A., et al.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Gepants for Acute and Preventive Migraine Treatment: A Narrative Review.Rissardo, JP., Caprara, ALF.[2022]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Focus on zavegepant: the first intranasal third-generation gepant.Scuteri, D., Tarsitano, A., Tonin, P., et al.[2022]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Calcitonin Gene-Related Peptide (CGRP)-Targeted Monoclonal Antibodies and Antagonists in Migraine: Current Evidence and Rationale.Cohen, F., Yuan, H., Silberstein, SD.[2023]
References
Perspectives on weight control in diabetes - Tirzepatide. [2023]
Tirzepatide: Clinical review of the "twincretin" injectable. [2023]
Adverse Events Related to Tirzepatide. [2023]
Efficacy and Safety of Tirzepatide in Type 2 Diabetes and Obesity Management. [2023]
Tirzepatide: First Approval. [2022]
Tirzepatide, a dual GIP/GLP-1 receptor co-agonist for the treatment of type 2 diabetes with unmatched effectiveness regrading glycaemic control and body weight reduction. [2022]
Efficacy and Safety of Tirzepatide in Adults With Type 2 Diabetes: A Perspective for Primary Care Providers. [2023]
Tirzepatide, the Newest Medication for Type 2 Diabetes: A Review of the Literature and Implications for Clinical Practice. [2023]
Beyond the Guidelines: A Narrative Review of Treatments on the Horizon for Migraine in Children and Adolescents. [2023]
The pharmacotherapeutic management of episodic and chronic migraine with gepants. [2023]
Gepants for Acute and Preventive Migraine Treatment: A Narrative Review. [2022]
Focus on zavegepant: the first intranasal third-generation gepant. [2022]
Calcitonin Gene-Related Peptide (CGRP)-Targeted Monoclonal Antibodies and Antagonists in Migraine: Current Evidence and Rationale. [2023]